BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2241972 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06698
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO DATA FROM THE TIME OF THE REPORTED EVENT AVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT ALSO CALLED TO REPORT THAT HE HAD BEEN RECEIVING AN EXCEEDS MAX LIMIT OF 125 UNITS NO DELIVERY ALARM AND WAS SEEKING ASSISTANCE WITH CHANGING IT. HE INDICATED THAT HIS BG LEVELS HAD BEEN OUT OF RANGE ALL DAY AND HE HAD GIVEN 4 INJECTIONS OF 25 UNITS. HE ALSO INDICATED DURING THE CALL WITH ANIMAS THAT THE PUMP WOULD NOT GIVE HIM ANY MORE INSULIN. THE PATIENT DENIED HAVING SYMPTOMS OF NAUSEA, VOMITING, SHORTNESS OF BREATH, OR DIZZINESS. THE PATIENT THAT HIS BG LEVEL WAS 400 MG/DL DURING THE MORNING TIME. AT THE TIME OF THE CALL WITH ANIMAS, THE PATIENT CLAIMED THAT HIS BG LEVEL WAS "HI" (BG POSSIBLY GREATER THAN 600 MG/DL) ON A METER. IT IS UNCLEAR IF THE PATIENT WAS GETTING THE MAX LIMIT/NO DELIVERY ALARM BEFORE OR AFTER HIS BG LEVEL REACHED "HI." THROUGH TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT DETERMINED THAT THE PUMP'S BOLUS AND TDD HISTORY WERE CORRECT. THE PATIENT'S TUBING, SITE, AND SET WERE REPORTEDLY FINE. THE CANNULA WAS NOT KINKED AND BLOOD WAS NOT EVIDENT. THE PATIENT'S INSULIN WAS REPORTEDLY "OLD" BUT IT IS UNKNOWN WHAT THE EXPIRATION DATE WAS. THE ANIMAS REPRESENTATIVE DETERMINED THAT THERE WAS NO EVIDENCE OF A POSSIBLE PUMP MALFUNCTION THAT CONTRIBUTED TO THE PATIENT'S INJURY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) MAILED A LETTER TO THE PATIENT SINCE HE COULD NOT BE REACHED BY TELEPHONE FOR FOLLOW-UP QUESTIONS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED AN ELEVATED BG LEVEL SUGGESTIVE OF A SERIOUS INJURY WHILE USING THE PUMP. HOWEVER, THE PATIENT INJURY CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR SINCE THE ALLEGED PRODUCT ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION IF DELIVERY IS INTERRUPTED FOR ANY REASON. IT IS UNKNOWN WHAT ACTIONS THE PATIENT TOOK PRIOR TO OBTAINING THE "HI" BLOOD GLUCOSE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening